Using 129Xe Gas MRI to Monitor Lung Disease Treatment Response

Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease

This study is testing a new type of MRI using a special gas to see how well treatments are working for people with interstitial lung diseases.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Duke University (Academic / other)
• Locations: 4 sites (Iowa City, Iowa and 3 other locations)
• Trial ID: NCT04855305 on ClinicalTrials.gov

What this trial studies

This multi-centered, NIH-sponsored study aims to develop an optimal protocol for utilizing noninvasive 129Xe gas exchange MRI to assess changes in disease activity in patients with interstitial lung diseases (ILDs). The study will involve outpatients who meet specific eligibility criteria, including age and health status, and will focus on standardizing the imaging technique to improve its effectiveness. By employing hyperpolarized 129Xe, the study seeks to enhance the visualization of lung function and therapy response over time.

Who should consider this trial

Good fit: Ideal candidates for this study are outpatients aged 18 and older without any diagnosed pulmonary conditions and a minimal smoking history.

Not a fit: Patients with existing pulmonary conditions, those who are pregnant or lactating, or individuals with contraindications to MRI will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a noninvasive method for monitoring treatment responses in patients with interstitial lung diseases, potentially leading to better management of their condition.

How similar studies have performed: While the use of hyperpolarized 129Xe MRI is a relatively novel approach, similar imaging techniques have shown promise in other studies, indicating potential for success.

Eligibility criteria

Inclusion/Exclusion Criteria for Healthy Volunteers

Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

1. Outpatients of either gender, age greater than or equal to 18 years
2. Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)
3. Subject has no diagnosed pulmonary conditions
4. Subject has not smoked in the previous 5 years
5. Smoking history, if any, is less than or equal to 5 pack-years
6. No history of using other inhaled products more than 1 time per week for \> 1 year

Exclusion Criteria: Subjects presenting with any of the following will not be included in the trial:

1. Subject is less than 18 years old
2. MRI is contraindicated based on responses to MRI screening questionnaire
3. Subject is pregnant or lactating
4. Resting oxygen saturation on room air \<90%
5. Respiratory illness of a bacterial or viral etiology within 30 days of MRI
6. Subject has history of any known ventricular cardiac arrhythmia
7. Subject has history of cardiac arrest within the last year
8. Subject does not fit into Xe vest coil used for MRI 129
9. Subject cannot hold his/her breath for 15 seconds
10. Subject deemed unlikely to be able to comply with instructions during imaging
11. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

Inclusion/Exclusion Criteria for Subjects with Interstitial Lung Disease

Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the trial:

1. Outpatients of either gender, age greater than or equal to 18 years
2. Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)
3. Clinical diagnosis of Interstitial Lung Disease made by a board certified pulmonologist using established criteria. We will not exclude individuals based on ILD type or severity of disease with the exception of the below criteria

Exclusion Criteria: Subjects presenting with any of the following will not be included in the trial:

1. Subject is less than 18 years old
2. MRI is contraindicated based on responses to MRI screening questionnaire
3. Subject is pregnant or lactating
4. Resting oxygen saturation \<90% on supplemental oxygen
5. Respiratory illness of a bacterial or viral etiology within 30 days of MRI
6. Subject has history of any known ventricular cardiac arrhythmia.
7. Subject has history of cardiac arrest within the last year
8. Subject does not fit into Xe vest coil used for MRI 129
9. Subject cannot hold his/her breath for 15 seconds
10. Subject deemed unlikely to be able to comply with instructions during imaging
11. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

Where this trial is running

Iowa City, Iowa and 3 other locations

• University of Iowa — Iowa City, Iowa, United States (Recruiting)
• Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
• University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Joseph Mammarappallil, MD — Duke University
• Study coordinator: Bastiaan Driehuys, PhD

Conditions Interstitial Lung Diseases